MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE BR DS W/ORTHCRD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 210712

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The expiration date is currently unavailable.Investigation summary: according to the information provided, it was reported that during the surgery of closed reduction of fracture, opened the packing(did not use), noted the anchor was deformed (as the photo shows).The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However a photo was provided.Upon visual inspection of the photo, it could be observed that the anchor is bent, also the sutures are tensioning from the anchor to the handle's groove.The shaft has no structural anomalies.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection of the photo, this complaint can be confirmed.The possible root cause can be attributed to the conditions of storage of the device.A combination of warmer temperature and tension can lead to a bent anchor.As per ifu 109002: store in a cool dry area.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Event Description

It was reported by the customer in (b)(6) that during a closed reduction of fracture procedure on (b)(6) 2021, it was observed that the lupine br ds w/orthcrd device was deformed upon opening its package.During in-house engineering evaluation of the photo provided by the customer, it was determined that the device was bent.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: LUPINE BR DS W/ORTHCRD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12032080
• MDR Text Key: 257200496
• Report Number: 1221934-2021-01931
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001101
• UDI-Public: 10886705001101
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 210712
• Device Catalogue Number: 210712
• Device Lot Number: 7L06677
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2021
• Initial Date FDA Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1